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Monoclonal Antibodies

Long-term Safety of Vedolizumab for Inflammatory Bowel Disease in Children

Q: Are there any known dangers or side effects to taking Vedolizumab?

Because Vedolizumab is still in Phase 2 trials, there is limited data supporting its efficacy. However, the available evidence does suggest that it is a safe medication, so it received a score of 2.

Q: Do we have any previous data to draw from regarding Vedolizumab's effects?

Vedolizumab was first trialed in 2015 at AZ Delta Roeselare, with 38 completed trials to date. Out of the 23 ongoing studies, a sizeable number are taking place in Toronto, Canada.

Q: At how many different locations is this trial currently taking place?

There are 22 recruiting patients for this trial including Toronto Hospital for Sick Children in Toronto, Ann &#x26; Robert H. Lurie Children's Hospital of Chicago in Chicago, and <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> University School of Medicine - <a href="https://www.withpower.com/clinical-trials/indianapolis-in">Indianapolis in</a> Indianapolis,as well as other sites 22 other locations.

Q: How many people are anticipated to take part in this experiment?

As of right now, this trial has stopped looking for patients. It was first posted on 7/30/2018 and edited for the last time on 5/19/2022. There are 614 other studies that might be recruiting participants with <a href="https://www.withpower.com/clinical-trials/colitis">colitis</a> and 23 trials involving Vedolizumab still actively enrolling patients.

Q: Has this particular clinical trial been conducted before?

first investigated in 2015, Vedolizumab underwent Phase 4 drug approval after a study of 260 patients. Presently, there are 23 active studies concerning Vedolizumab being conducted across 42 countries and 312 cities.

Q: Does this research project restrict its volunteers to those over 55 years old?

The age group that this study is looking to enroll are children aged 2-17 years old.

Q: Who does this research require for subjects?

This clinical study is looking for 59 children and adolescents between the ages of 2-17 who have colitis. The other requirements for participants are that they be male or female, with <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a> or <a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a>, and were aged 2-17 at the time of randomization for Study MLN0002-2003. (It should be noted that a participant remains eligible to participate in this study after they turn 18 as long as they still meet the inclusion criteria and do not meet any exclusion criteria.)

Q: Is there still room for patients who want to join this trial?

According to the latest update on clinicaltrials.gov, this study is no longer recruiting patients for participation. This trial was initially posted on July 30th 2018 and updated May 19th 2022. There are 637 other trials at present which are actively recruiting patients.

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has completed Study MLN0002-2003 and achieved clinical response as defined by specific criteria

Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 8 years

Awards & highlights

Study Summary

This trial will study how safe it is to give the drug vedolizumab to children with either UC or CD over a long period of time.

Who is the study for?

This trial is for children and teens aged 2-17 with Ulcerative Colitis or Crohn's Disease who have previously responded to Vedolizumab treatment. They must be up-to-date on vaccinations, may use certain antibiotics, and can continue in the study after turning 18 if eligible. Pregnant or lactating females, those with serious health issues, or allergies to Vedolizumab cannot participate.Check my eligibility

What is being tested?

The trial is testing the long-term safety of an IV medication called Vedolizumab in young patients with inflammatory bowel diseases like UC and CD. It aims to understand how safe it is when used over a longer period.See study design

What are the potential side effects?

While not specified here, common side effects of Vedolizumab may include headache, joint pain, nausea, fever, infections, fatigue and infusion-related reactions such as redness or irritation at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed Study MLN0002-2003 and met its success criteria.

Select...

I was between 2 to 17 years old when I joined the MLN0002-2003 study for UC or CD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

Secondary outcome measures

Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years

Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 8 Years

Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years

+6 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713

Crohn's disease

Gastrointestinal motility disorder

Paronychia

Viral infection

Colitis ulcerative

100%

80%

60%

40%

20%

Study treatment Arm

Vedolizumab 300 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vedolizumab Low Dose GroupExperimental Treatment1 Intervention

Participants with UC or CD having baseline weight of >= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of < 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Group II: Vedolizumab High Dose GroupExperimental Treatment1 Intervention

Participants with UC or CD having baseline weight of greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

2009

Completed Phase 4

~10330

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,971 Total Patients Enrolled

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,178,203 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

489,621 Total Patients Enrolled

Media Library

Vedolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03196427 — Phase 2

Crohn's Disease Research Study Groups: Vedolizumab High Dose Group, Vedolizumab Low Dose Group

Crohn's Disease Clinical Trial 2023: Vedolizumab Highlights & Side Effects. Trial Name: NCT03196427 — Phase 2

Vedolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03196427 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known dangers or side effects to taking Vedolizumab?

"Because Vedolizumab is still in Phase 2 trials, there is limited data supporting its efficacy. However, the available evidence does suggest that it is a safe medication, so it received a score of 2."

Answered by AI

Do we have any previous data to draw from regarding Vedolizumab's effects?

"Vedolizumab was first trialed in 2015 at AZ Delta Roeselare, with 38 completed trials to date. Out of the 23 ongoing studies, a sizeable number are taking place in Toronto, Canada."

Answered by AI

At how many different locations is this trial currently taking place?

"There are 22 recruiting patients for this trial including Toronto Hospital for Sick Children in Toronto, Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago, and Indiana University School of Medicine - Indianapolis in Indianapolis,as well as other sites 22 other locations."

Answered by AI

How many people are anticipated to take part in this experiment?

"As of right now, this trial has stopped looking for patients. It was first posted on 7/30/2018 and edited for the last time on 5/19/2022. There are 614 other studies that might be recruiting participants with colitis and 23 trials involving Vedolizumab still actively enrolling patients."

Answered by AI

Has this particular clinical trial been conducted before?

"first investigated in 2015, Vedolizumab underwent Phase 4 drug approval after a study of 260 patients. Presently, there are 23 active studies concerning Vedolizumab being conducted across 42 countries and 312 cities."

Answered by AI

Does this research project restrict its volunteers to those over 55 years old?

"The age group that this study is looking to enroll are children aged 2-17 years old."

Answered by AI

Who does this research require for subjects?

"This clinical study is looking for 59 children and adolescents between the ages of 2-17 who have colitis. The other requirements for participants are that they be male or female, with ulcerative colitis or Crohn's disease, and were aged 2-17 at the time of randomization for Study MLN0002-2003. (It should be noted that a participant remains eligible to participate in this study after they turn 18 as long as they still meet the inclusion criteria and do not meet any exclusion criteria.)"

Answered by AI

Is there still room for patients who want to join this trial?

"According to the latest update on clinicaltrials.gov, this study is no longer recruiting patients for participation. This trial was initially posted on July 30th 2018 and updated May 19th 2022. There are 637 other trials at present which are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

2018. "Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03196427.

All > Inflammatory Bowel Disease > Colitis